Workshop                                 >Japanese

Ethical Issues of Science & Technology for the New Millennium◆

               - Emerging Bioethics in R & D -


  Date: 13 November, 2002 10:00-15:30

  Venue: The United Nations University / The Institute of Advanced Studies

  Organizers: Japan Society for Future Studies, UNU/IAS


Developments in science and technology have contributed so much to improve   our lives in the recent history. Through the course of its development, society has tried to adapt to the emerging ideas and practices and accommodate them in its ethical values. If the pace of developments in science and technology is faster than the pace of the society in adapting to these changes, the full positive potential of such developments may not be realized by the society. Therefore looking into ethics in response to developments in science and technology deserve high importance. In September, 2001, JSFS and UNU/IAS co-organized the 1st workshop entitled on this subject “Ethical Issues of Science & Technology for the New Millennium”. In an attempt to continue that dialogue , the current workshop would focus on ethical issues in the field of life sciences in general and application of modern biotechnology to human in particular.



  Opening   Mr. Yujiro Hayashi, Chairman, JSFS

          Prof. A.H.Zakri, Director, UNU/IAS

    (Roundtable 1 Ethical Issues in Life Science R&D)

10:10 - 10:30 Prof. Hiromichi Kimura, Univ. of Tokyo

          Pharmaceutical Products R & D and Its Ethical Issues

10:30 - 10:50 Mr. Hisao Tsubamoto, Manager, Pfizer Pharmaceutical Inc.

          Ethical Considerations on Conducting Clinical Trials

10:50 - 11:10 Dr. Setsuo Hasegawa, Director, Sekino Clinical Pharmacology Clinic

          On the Ethical Aspects of Genomic Analysis in the Clinical Study

11:10 - 12:00 Panel Discussion Moderator : Prof. Kimura

12:00 - 12:30 Lunch Break

    (Roundtable 2 Future Policy Making for Life Science)

12:30 - 12:50 Prof. A. H. Zakri, Director, UNU/IAS

          International Concerns: Protecting Common Human Values

12:50 - 13:10 Prof. Darryl R.J. Macer, Univ. of Tsukuba

          Implication of Globalization on Ethical Values

13:10 - 13:30 Dr. Tetsuo Saito, Congressman

          Public Values and Future S & T Development

                       ; Political Implications

13:30 - 13:50 Prof. Shin’ichi Nishikawa, Univ. of Kyoto

          Ethical Issues behind Stem Cell Therapy

13:50 - 15:20 Panel Discussion Moderator : Prof. A. H. Zakri


(Roundtable 1)

Pharmaceutical Products R&D and Its Ethical Issues

                                    Dr. Hiromichi Kimura

In the first section of this presentation the overview of the new drugs R&D is presented, and then the ethical issues associated with the process is discussed.

In conducting clinical trials, it is important to comply with the ICH GCP requirements. GCP is an ethical and scientific quality standard for trials. ICH aims to harmonize GCPs globally.

Despite the ICH, there are a number of issues associated with importing foreign drugs into Japan. It should be noted that in Japan, the social/medical background, as well as the regulatory environment prohibit foreign drugs from entering into the Japan market.

Japan lagged behind other developed countries in the field of clinical trials. In the recent past, however, increased understandings about the importance of clinical trials have improved the environment for clinical trials.

Despite the GCP, there are still a number of ethical issues to be addressed. Furthermore, advances in bio-technology and genetic engineering pose new ethical challenges. As these technologies will have broad implications for all humanity and living things, it is important to develop additional guidelines that adequately reflect the application of the new technologies.

Dr. Hiromichi Kimura is Professor of the Pharmaco-Business Innovation Course at the Graduate School of Pharmaceutical Sciences, the University of Tokyo. He is also founder and CEO of Life Science Management Inc.

After receiving a Ph.D. in pharmaceutical sciences from the University of Tokyo, Dr. Kimura joined Kyowa Hakko Kogyo as a product manager with responsibilities including the management of clinical trials and new drug approval applications.

After receiving his MBA from Stanford, he has held a number of senior management and CEO positions in the life science as well as financial industries.

Ethical Considerations on Conducting Clinical Trials

- Frontline of New Drug Development -

                                 Pfizer Pharmaceuticals Inc.

                                    Hisao Tsubamoto

Pharmaceutical companies research and develop innovative and valuable products to contribute to health and affluence of people in the world. No one contradicts the influence that the medical supplies which have been marketed until now contributed to the growth of an average life and the improvement of quality of life.

20-30 medical supplies containing new chemical ingredients are approved as products every year, and supplied to market in Japan. How have these new medicine been developed? There are three major elements of medical supplies; quality, safety and efficacy. Even if they lack of one of the elements, we cannot use them as medical supplies.

A process to develop new medical supplies may express, in other words, a process to confirm their quality, safety and efficacy. At first we estimate the safety and efficacy in animal experimentation, however there is a limit to put data of animals in human. Therefore, it is necessary to confirm the safety and efficacy in order to use them as medical supplies in the world, by really administration to patients. We call this examination “clinical trial”. Of course we do carry out sufficient animal test before conducting clinical trials and push it forward step-by-step while ensuring safety.

In carrying out clinical trials, in particular ethical attitude and scientific attitude are important. Ethics in clinical trials depend on conditions such as how to keep human rights of the patients who participate in clinical trials, whether we apply the method to reduce the risk against patients to a minimum in comparison with prospective profit, whether care and security when side effects occur are confirmed. On the other hand, an assurance of science should be the premise of ethics that clinical trials are planned based on data provided by previous studies, and have clear purposes and methods, and are carried out by qualified institutions/ doctors. The rule that aims at to assure the reliability of data in addition to this ethical and scientific attitude, is called Good Clinical Practice (GCP). We, pharmaceutical companies try to develop useful new medical supplies by observing GCP and accomplishing clinical trials.

I am to explain about GCP at our workshop a little more in detail.

Mr. Hisao Tsubamoto is Manager of Regulatory Strategy and Registration II, Pfizer Pharmaceuticals Inc.

On the Ethical Aspects of Genomic Analysis in the Clinical Study

                                   Dr. Setsuo Hasegawa

In the advent of post genome era, clinical studies associated with drug development are likely to be changed drastically. Especially, in phase-I studies where healthy adults are voluntarily enrolled for a trial subject, noticeable improvement will be expected.

With introduction of pharmacogenomics, evidence-based medications rested on genome information would become available in addition to improve the safe for subjects and shorten the term of clinical studies more than ever before. Coincidentally, security issues over genome information in clinical studies are currently coming up to the surface as a critical issue associated with the protection of individual privacy.

Clinical studies are intended to be implemented in nature to make assessments on both safety and drug efficacy in trial subjects through scientific analysis based on the view point from phamacokinetics and pharmacodynamics. Besides, there is an assumption that the benefit of each trial subject is the first priority in clinical studies as it was advocated in the World Medical Association Declaration of Helsinki.

Regarding phamacokinetics, clinical investigations on single nucleotide polymorphism (SNP) of drug metabolism have already been set out one after the another to conduct clinical studies in classified subject group of extensive metabolizer or poor metabolizer.

The immediate prospect is that there may be a research of targeted receptor-related genes followed by haplotype analysis on genes for common illness under the circumstances that the International HAPMAP Project was announced to be launched, in October, 2002.

In the meanwhile, we are now being stressed for more prompt action to take in clinical studies in order to make it available to have tailor-made medications provided by the support of genomic-base drug discoveries. For that purpose, it is imperative for us to improve not only the management of genome information but also medical ethics.

Here are what we believe to be expected to do or make adjustment to satisfy the above needs:

>Constitution of the Institutional Ethics Committee

>How to link samples and de-identification data

>Disclosure of gene analysis information

>How to counsel

>Safekeeping of DNA samples

>Destruction of DNA samples

We do strongly hope that these matters are allowed to put into law and practicable and detailed ethical regulations will be established in the nearest future.

Dr.Hasegawa is Director, Sekino Clinical Pharmacology Clinic.

(Roundtable 2)

Policy of Life Science and Bioethics in Japan

- Focus on Bioethics -

                                   Tetsuo Saito

                                   Member of Parliament

◇ Life science is related to our life closely and expected to correspondence to aging society.

Government organizes "the BT(Biotechnology) Strategic Force" that the Prime Minister presides over and examines a strategy of life science / biotechnology policy for the future.

◇ Development of life science raises ethical, legal and social issues to us. These are generally called “bioethical issues”. I think that we examine bioethical Issues steadily and have to send various information.

◇ It is human cloning technology, human ES cells, and human genome research that are examined in Japan.

@ Human cloning technology

In Nov., 2000, "Law for regulation on human cloning technology" was established. This law prohibit reproductive human cloning by prohibition on putting embryos into human and animal uterus. Violated it, it inflict severe punishment; imprisonment up to 10 years of in jail or a fine equal to or less than 10,000,000 yen or both.

A Human ES cells

In Ministry of Education released "Guidelines for Deviation and Utilization of Human Embryonic Stem Cells” in the end of September, 2001. Based on this Guidelines, studies for production of Human ES cells is started in Japan. In addition, studies by using the ES cells that were imported from U.S.A. and Australia are also started.

B Human genome research

Council for Science and Technology (CST)’s bioethics committee released "A basic principle on human genome research" in June, 2000. Furthermore, "An Ethical Guidelines for Human Genome Research" is released jointly by Ministry of Education, Culture, Sports, Science and Technology, Ministry of Health, Labour and Welfare and Ministry of Economy, Trade and Industry, and it is enforced since April, 2001.

◇ Life science develops everyday, and Government and public administration must address new issues. It may be enter in era that we should think about a common principle how should we address life science make progress.

Ethical Issues behind Stem Cell Therapy

                                  Prof. Shin’ichi Nishikawa,

                                        Univ. of Kyoto

Discussion on bioethical issues is a boom today.
In this background, medical biology based on molecular biology invents a lot knowledge of the precision beyond comparison, and the recent progress has been available for various technology based on it.

On the other hand, because the technology based on life science, it is a fact that some of people are concerned about in operating life, and their opinion is accepted by most of people.

Of course it is a fact that there is the same problem in every technology. It is too numerous to comprehensively list here, such as atomic energy, an environmental problem, the use of plastic and etc. It has been argued about this issue whether "neutrality theorem of science" was possible until now.

However, as for the medical biology, we cannot conclude a simple neutral theorem at the point that is discovery itself of ourselves (a human being).

In particular, reproduction medicine may be a menace for culture at a point to challenge partially our recognition that is the most important undercurrent of our culture, "vain life". Francis Fukuyama regard this issue as an opposition between culture and a fact of biology and conclude that we should solve it on the basis of superiority of culture.

At this roundtable, after having easily explained two concrete examples, molecular biology and reproduction medicine, I would like to remark that relation between medicine biology and society is different from traditional relation between science and society, as an important background of bioethical issues.

By the way, Fukuyama gives this problem a clear answer as roots of human dignity in superiority of culture, but Can his idea make our social decision ? Actually, in modern society that mixed various opinions, how should there be social decision making?

This issue is going to become an important field as sociology of science now. I argue about this issue and describe the personal opinion that can be joint with other opinions as us of a situation promoting advanced medical care.